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Tivozanib · 2 trials · 2 indications
Comparison of the PFS of tivozanib in combination with nivolumab to tivozanib in subjects with RCC who have progressed following 1 or 2 lines of therapy. PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease \[PD\], radiological) according to Response Evaluation Criteria In Solid Tumors (RECIST), or death due to any reasons whichever comes first.
A traditional escalation rule, also known as "3 + 3" rule, will be used for this study. Subjects are treated in groups of 3 with each receiving the same dose. If none of the 3 subjects experience a DLT within Cycle 1, the next group of 3 subjects receives the next higher dose, otherwise, the group will expand to 6 subjects treated at the same dose level. If ≤ 1 of the 6 subjects treated at that dose level experience a DLT within Cycle 1, the trial will continue to the next higher dose level. If ≥ 2 of the 6 experience a DLT at the dose level within Cycle 1, then escalation stops at that level and the prior dose level will be considered the MTD. If MTD is not identified and both dose levels are tolerated, 1.5 mg will be considered the recommended Phase II dose (RP2D) for the expansion.
| Arm | Type | Description |
|---|---|---|
| Tivozanib in Combination with Nivolumab | EXPERIMENTAL | Subjects with advanced RCC will receive 0.89 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug and nivolumab every 4 weeks on Day 1 of each Cycle, until disease progression or unacceptable toxicities occur, other withdrawal criteria are met, or completion of 2 years of treatment \[for nivolumab\] whichever occurs first. |
| Tivozanib | EXPERIMENTAL | Subjects with advanced RCC will receive 1.34 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug until disease progression or unacceptable toxicities occur, or other withdrawal criteria are met. |
| Tivozanib (AV-951) plus Nivolumab | EXPERIMENTAL | Tivozanib plus Nivolumab:Tivozanib will be administered once daily for 3 weeks followed by 1 week off. Nivolumab will be administered every 2 weeks starting on Day 1. |
| Name | Type | Description |
|---|---|---|
| Tivozanib | DRUG | Tivozanib will be administered orally. |
| Nivolumab | DRUG | Nivolumab will be administered via intravenous infusion. |
Inclusion Criteria: * Radiographic disease progression during or following at least 6 weeks of treatment with ICI for locally advanced or metastatic RCC with a clear cell component either in first- or second-line treatment. * Subjects must have recovered from the adverse events of prior therapy to ...
Tivozanib is an investigational small molecule being studied for the treatment of Renal Cell Carcinoma. It is currently in clinical development, with trials evaluating it both as a monotherapy and in combination with nivolumab for this indication.
Tivozanib is a kinase inhibitor, belonging to the -nib class of drugs. It works by targeting kinases, which are enzymes involved in cell signaling and growth. This mechanism is being investigated for its potential anti-cancer effects in Renal Cell Carcinoma.
Tivozanib is being developed by Bristol-Myers Squibb Company, which is publicly traded under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in Renal Cell Carcinoma.
Tivozanib is in Phase 1 clinical development. While one Phase 1 trial has been completed, an additional Phase 3 trial is active but not recruiting. The drug remains investigational and has not been approved by regulatory authorities.
Tivozanib is being studied in two clinical trials. NCT03136627 is a completed Phase 1/2 study of tivozanib in combination with nivolumab in Renal Cell Carcinoma. NCT04987203 is an active Phase 3 trial comparing tivozanib plus nivolumab to tivozanib monotherapy in the same condition.
Tivozanib is also known by other names, though specific alternative names are not provided. It is being studied under its generic name, tivozanib, in clinical trials for Renal Cell Carcinoma.